Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone

NCT04586660 | Active Not Recruiting Phase 4

• 1 other identifier: 20180119
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 10

Brief Summary

The study aims to evaluate the efficacy of XGEVA® in Chinese participants with giant cell tumor of bone (GCTB).

Conditions

Giant Cell Tumor of Bone

Keywords

Giant cell tumor of bone (GCTB); XGEVA®

Outcome Measures

Primary Outcomes (1)

• Objective tumor response

  Objective tumor response is defined as the percentage of participants with complete response (CR) or partial response (PR) evaluated based on European Organisation for Research and Treatment of Cancer (EORTC) criteria and Response Evaluation Criteria in Solid Tumors (RECIST).

  Up to 36 months

Secondary Outcomes (10)

• Time to disease progression or recurrence in participants with unsalvageable giant cell tumor of bone (GCTM) (Cohort 1 only)

  From baseline until end of treatment, up to a maximum of 36 months

• Number of participants with surgically salvageable giant cell tumor of bone (GCTB) after treatment (Cohort 1 only)

  Month 36

• Time to disease progression or recurrence for participants with complete response (CR) from time of surgery (Cohort 2 only)

  From time of surgery until end of treatment, up to a maximum of 36 months

• Number of participants who do not require surgery in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only)

  Up to 36 months

• Number of participants with surgically downstaging in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only)

  Up to 36 months

Study Arms (2)

Surgically unsalvageable disease

EXPERIMENTAL

Participants with surgically unsalvageable disease (eg, sacral, spinal Giant cell tumor of bone \[GCTB\], or multiple lesions including pulmonary metastases).

Drug: XGEVA®

Surgically salvageable disease

EXPERIMENTAL

Participants with surgically salvageable disease whose planned on-study surgery is associated with severe morbidity (eg, joint resection, limb amputation, or hemipelvectomy).

Drug: XGEVA®

Interventions

XGEVA® DRUG

Participants will receive XGEVA® 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15.

Also known as: Denosumab

Surgically salvageable disease; Surgically unsalvageable disease

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has provided informed consent prior to initiation of any study specific activities/procedures.
• Chinese male or female adults aged ≥ 18 years or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone \[eg, humerus with closed growth epiphyseal plate\]) ≥ 12 years of age.
• Skeletally mature adolescents must weigh at least 45 kg.
• Pathologically confirmed giant cell tumor of bone (GCTB) within 1 year before study enrollment (central pathology review).
• Measurable evidence of active disease within 1 year before study enrollment.
• Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) OR participants whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity.
• Eastern Cooperative Oncology Group performance status (\[ECOG PS\] of ≤ 2).

You may not qualify if:

• Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma.
• Known diagnosis of malignancy derived from non-musculoskeletal system within the past 5 years (participants with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted).
• Known or suspected current diagnosis of brown cell tumor of bone or Paget's disease.
• Known or suspected current diagnosis of non GCTB giant cell-rich tumors.
• Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw.
• Active dental or jaw condition which requires oral surgery, including tooth extraction.
• Non-healed wound after dental/oral surgery.
• Planned invasive dental procedure for the course of the study.
• Any planned treatment with intravenous (IV) or oral bisphosphonates during the study.
• Currently receiving other GCTB-specific treatment (eg, radiation, chemotherapy, or embolization).
• Current or previous XGEVA treatment
• Concurrent bisphosphonate treatment
• Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
• Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 months after the last dose of XGEVA.
• Female participants of childbearing potential unwilling to use 2 highly effective method of contraception or acceptable method of effective contraception during treatment and for an additional 5 months after the last dose of XGEVA.

Sponsors & Collaborators

• Amgen: lead

Study Sites (10)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

Peking University Peoples Hospital

Beijing, Beijing Municipality, 100044, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

The Third Affiliated Hospital Of Southern Medical University

Guangzhou, Guangdong, 510630, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510663, China

Location

Harbin Meidical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

Tangdu Hospital of Air Force Medical University

Xi'an, Shaanxi, 710032, China

Location

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: August 17, 2023
• Primary Completion (Estimated): March 7, 2028
• Study Completion (Estimated): March 7, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

TW (2); CN (8)